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Application Type Guidance

Version Date: July 2017

Based on the type of project you propose to conduct, please select one of these options. Your selection will result in questions specific to the application type. Please review the descriptions of each type of application before making your selection. If you are still unsure of the type of application to select, please contact the IRB office.

Initial Review Application: Full Review: This application type should be selected for studies that do not fit any of the other categories listed below.

Initial Review Application: Non-Exempt Medical Records Review: This application type should be selected for studies that solely involve the collection of medical information from medical charts or databases, or follow-up medical information from the subject. If the research study involves any other activities or interventions, such as testing of tissue, a blood draw or other medical procedures, or the creation of a database, this application type should not be selected. In addition, if the study qualifies for exemption, this application type should not be selected. Additional guidance for how to fill out a non-exempt medical records application can be found here.

Initial Review Application: Exemption (includes projects that may qualify as not research, such as quality assurance or quality improvement): The IRB is responsible for the protection of human subjects in research as defined in the federal Common Rule. Projects that do not constitute research and/or do not involve human subjects may be exempt from further IRB review. In addition, the Common Rule identifies six categories of research that may be eligible for exemption from further IRB review, including certain types of educational research, surveys, interviews, and research using existing, anonymous data or specimens. An application must be submitted to the IRB to determine whether the project qualifies for exemption from further IRB review. Only an IRB can make this determination. If you believe your project qualifies for exemption from further IRB review, please select this application type.

Training grant, umbrella grant or core grant: This application type should be selected when the sole purpose is to obtain approval of a grant for funding purpose. DO NOT select this application type if you are requesting approval for activities involving human subjects.

Statistical Data Analysis Center (SDAC)/Reading Center: This application type should be selected when the UW's role is limited to analysis of data, samples, or images on behalf of a multi-site study (e.g. Statistical Data Analysis Center, Fundus Photograph Reading Center, Core Laboratory Analysis Center).

National Cancer Institute Central IRB (NCI-CIRB) Facilitated Review: The University of Wisconsin-Madison has agreed to defer IRB review of some protocols to the National Cancer Institute Central IRB (NCI-CIRB). Currently, this agreement is in place only for protocols approved by the NCI-CIRB involving adults. This application type should be selected if the study has been reviewed by NCI-CIRB and involves only adult subjects. NOTE: You will be required to complete additional sections of this application, in addition to the NCI-CIRB application materials.

Request for Deferral of IRB oversight to a non-UW-Madison IRB: This application type should be selected if you are requesting that the UW-Madison Health Sciences or Minimal Risk IRB defer IRB oversight to a non-UW-Madison IRB. NOTE: IRB review of activities occurring at the Madison VA or conducted by a researcher under their Madison VA or UWHC appointment (or using VA or UWHC facilities) CANNOT be deferred to another institution.

Humanitarian Use Device (HUD): A HUD is a device that is intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer then 4,000 individuals in the United States per year. A HUD is approved for marketing through a humanitarian device exemption (HDE) application filed in accordance with the requirements of the Federal Food, Drug and Cosmetic Act (Act). Under the Act, a HUD may be used only after IRB review and approval. If you are requesting to use the HUD for clinical treatment and not research, this application type should be selected. However, if you seek to use the HUD as part of a clinical investigation or research project designed to obtain data to support a pre-market approval application, please select Initial Review Application: Full Review. For further information, refer to Humanitarian Use Device Policy.

Protocol Development Activities (PDA): The Protocol Development Activities Only application type is meant to facilitate the submission of grant applications to the IRB for review when research activities involving human subjects are planned in future but have not been finalized (e.g., the grant incorporates a planning stage) or when an agency or organization requires IRB approval of the concept as part of the application for funding. Only planning activities that do not involve human subjects can be covered by this administrative approval. In order to obtain approval to perform research activities involving human subjects, a separate Initial Review Application or Application for Exemption from IRB Review will be required. For further information, refer to Protocol Development Activities (PDA) Guidance .

Emergency OR one-time use of drug, biologic or device: This application type should be selected for the emergency use (generally has already occurred) of a drug or device, or the compassionate use (has yet to occur) of a drug or device in a single patient. If this request is not emergent or involves more than a single patient, please select Initial Review Application: Full Review. For further information, refer to Emergency, One-Time-Use .

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Keywords:initial review, full review, IR, non exempt medical records review, non-exempt, NMR, exemption, EX, protocol development activities, PDA, humanitarian use device, HUD, training grant, umbrella grant, core grant, statistical data analysis center, reading center, SDAC, NCI-CIRB, request for deferral, emergency, one-time use, compassionate use, treatment use, umbrella study registry retrospectiveDoc ID:19534
Owner:Faye L.Group:Health Sciences IRBs
Created:2011-08-03 18:00 CSTUpdated:2017-07-21 08:27 CST
Sites:Health Sciences IRBs
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